Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Location status: Recruiting
Recruiting
NCT Number: NCT07634549
Rice-derived Recombinant Human Serum Albumin for the Treatment of Hypoalbuminemia After Hepatectomy: A Prospective, Single-Arm, Exploratory Clinical Trial
Rice-derived recombinant human serum albumin (OsrHSA) possesses an identical primary, secondary, and higher-order structure to plasma-derived human albumin. Through innovative production technology, it fundamentally circumvents the supply limitations and viral contamination risks associated with plasma sources, offering a novel solution to address clinical unmet needs. Existing research data have demonstrated that its efficacy and safety are non-inferior to plasma-derived human albumin in patients with cirrhosis complicated by hypoalbuminemia. However, no study has yet explored the safety and efficacy of OsrHSA in patients with postoperative hypoalbuminemia following hepatectomy. This study is a prospective, single-arm, small-sample, exploratory clinical trial aimed at evaluating the efficacy and safety of recombinant human serum albumin injection (rice) (OsrHSA) in patients with hypoalbuminemia after hepatectomy. All trial participants will receive daily intravenous infusion of 20 g OsrHSA (20%, 50 mL) starting from the day when postoperative hypoalbuminemia (<30 g/L) is identified, with concurrent monitoring of serum albumin levels. The primary endpoints are the percentage of trial participants achieving serum albumin ≥35 g/L within one week, and the incidence of adverse drug reactions.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Able to understand and willing to sign the informed consent form.
- Male or female; age ≥18 years and ≤80 years.
- Planned for or has undergone hepatectomy.
- Developed postoperative hypoalbuminemia, defined as serum albumin ≤30 g/L .
Exclusion criteria
- Known hypersensitivity to the active ingredient or any excipient of the investigational drug
- Complicated with any of the following diseases or conditions: severe renal disease requiring hemodialysis, active upper gastrointestinal bleeding, hepatic encephalopathy Grade III or IV.
- Pregnant or lactating women.
- HIV positive.
- Heart failure classified as Stage C or D according to ACCF/AHA criteria.
- History of organ transplantation.
- Mental status that prevents the participant from understanding the nature, scope, and consequences of the study.
- Any clinical condition that the investigator considers makes the trial participant unsuitable for participation in the trial.
Treatment and study plan
Rice-derived recombinant human serum albumin (OsrHSA)
DrugAll trial participants will receive daily intravenous infusion of 20 g Rice-derived recombinant human serum albumin (OsrHSA, 20%, 50 mL) starting from the day when postoperative hypoalbuminemia is identified, for a maximum duration of 7 days, with concurrent monitoring of serum albumin levels. Study drug administration will be discontinued once serum albumin reaches ≥35 g/L, and participants will enter the follow-up period. Each trial participant will undergo one follow-up visit within 30 days after treatment.
Primary outcomes
-
The percentage of trial participants achieving serum albumin ≥35 g/L within one week
Time frame: one week after administrating rice-derived recombinant human serum albumin
Secondary outcomes
-
Time to serum albumin ≥35 g/L (days)
Time frame: one week after administrating rice-derived recombinant human serum albumin
-
adverse event
Time frame: 30 days after administrating rice-derived recombinant human serum albumin
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Cheng Qi
Other
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 9, 2026
- Registry last updated
- Jun 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.